The present invention relates to a novel process for preparing a double sterile package. More particularly, it relates to sealing an inner package through a sealed outer package while allowing the sealed inner package free movement in the outer package.
Sterile packages intended for use in sterile zones must meet exacting requirements. The sterilized condition within and without the inner package must be maintained while the entry of contaminants into the packages must be prevented. The package must be able to resist variations in environmental conditions. Additionally, the sterile package must be able to be easily and quickly opened, without recourse to implements, thereby permiting the ready removal of the sterile contents without disrupting the sterility thereof.
Current methods used to prepare double sterile packages include sterilizing an inner package open on one end. The wrapped sterile package is then dried in an oven and stored in a dry area, i.e., an environment free from moisture, until the final sealing of this inner package takes place in a clean room using aseptic techniques, where the package is again sterilized before being heat sealed. Thus, the numerous steps in this process and the need for a dry area and a sterile area, are both costly and time consuming. This lengthy procedure can adversely effect the quality of the contents as well as possible risk of contamination.
U.S. Pat. No. 3,815,315 discloses a sterile package whose gaseous contents are either evacuated or replaced with inert gas prior to sealing. The package is then held in a dry room area, and subsequently sterilized in a sterile area commonly called a clean room before the final sealing step.
There remains a need for an efficient and economical method of preparing a sterile double package.